At a glance
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Phase II Study of the Anti-Ganglioside GD3 Mouse/Human Chimeric Antibody KW2871 Combined With High Dose Interferon-α2b in Patients With Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating HDI and KW2871 for Metastatic Melanoma and Cutaneous Melanoma. Completed, enrolled 36 participants across 2 sites.
Detailed Summary
This was a Phase 2, open-label study of KW2871 (ecromeximab) in combination with high-dose interferon-α2b (HDI) in patients with metastatic melanoma. The primary objectives of this study were to assess progression-free survival (PFS) and safety. The secondary objectives were to assess the objective response rate, KW2871 pharmacokinetics (PK), and other exploratory immunology as indicated (e.g., development of human anti-chimeric antibodies \[HACA\], activity of antibody-dependent cell-mediated cytotoxicity \[ADCC\] and complement-dependent cytotoxicity \[CDC\] in peripheral blood, number and functional state of tumor-infiltrating immune cells and expression of GD3 in immune and tumor cells of tumor biopsies, and markers of interferon \[IFN\] response/resistance and markers of resistance to ADCC/CDC in peripheral blood mononuclear cells \[PBMCs\]).
Study Details
Timeline
Interventions
20 MU/m\^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m\^2 SC 3 days/week until disease progression
5 mg/m\^2 IV every 2 weeks until disease progression
10 mg/m\^2 IV every 2 weeks until disease progression
20 mg/m\^2 IV every 2 weeks until disease progression